Association of Sleep Quality With Pathologic Staging, Acupuncture Treatment in Patients With Chronic Atrophic Gastritis: a Cross-sectional Study

NCT06912178 | Not Yet Recruiting DMC

• 1 other identifier: 20250303032132260
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In order to inform clinical treatment decisions and maximize treatment outcomes, this observational study set out to examine the relationship between pathological severity and sleep quality in patients with CAG. The idea that "if the stomach is not in harmony, you will be restless" is supported by this evidence from traditional Chinese medicine. Assessing patients' knowledge and acceptance of acupuncture therapy, determining the current general trend in CAG treatment, and assessing the initial effectiveness of acupuncture therapy in treating CAG with sleep disturbances. It is envisaged that the aforementioned investigations will aid in further refining the clinical research strategy of acupuncture and moxibustion with CAG with sleep disorders, enhance the effectiveness of treatment, and offer a more cost-effective and practical choice for treating CAG with sleep disorders. The primary research issue is: can the traditional Chinese medical notion of "restlessness due to disharmony of the stomach" be validated in order to ascertain whether there is a correlation between pathological severity and sleep quality in patients with chronic atrophic gastritis? The pathological conditions of CAG patients were gathered based on the most recent gastroscopy report within a year, and the patients' sleep quality scores from the previous month were gathered via a questionnaire.

Conditions

Chronic Atrophic Gastritis (CAG)

Keywords

chronic atrophic gastritis; sleep quality; OLGA; OLGIM; pathologic; acupuncture; cross-sectional

Outcome Measures

Primary Outcomes (1)

• The correlation coefficient between various pathological stages of Operative Link on Gastritis Assessment (OLGA) and Operative Link on Gastric Intestinal Metaplasia (OLGIM) and sleep quality in patients with chronic atrophic gastritis (CAG) is the main o

  General condition (age, gender, height, weight, etc.), occupation, personal and family history, Helicobacter pylori infection history, acupuncture treatment, Pittsburgh sleep quality index, serum pepsinogen index, gastroscopy results, and clinical data (OLGA and OLGIM for gastric mucosal histopathology) were among the information that the researchers gathered. The association between the histological stages of OLGA and OLGIM in stomach mucosal histopathology and the sleep quality index in CAG patients was then examined by the researchers.

  Gastroscopy and pathology reports within one year and sleep quality assessment within one week of participant enrollment

Secondary Outcomes (1)

• Acupuncture treatment response and sleep quality relationships, as well as other pertinent risk factors, were secondary outcomes

  Patient's treatment to date after diagnosis of chronic atrophic gastritis, and whether participant has received acupuncture in the last 3 months

Interventions

Acupuncture OTHER

Whether or not a patient has been treated with acupuncture will be one of the exposure factors of interest in the study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This multicenter clinical investigation is coordinated by Zhejiang Chinese Medical University (ZCMU) with participant enrollment conducted at the Third Affiliated Hospital of ZCMU. To establish a conclusive diagnosis for each participant, the researchers conduct an upper gastrointestinal endoscopy screening and assess serum pepsinogen levels during recruitment, subsequently identifying and continuously enrolling all eligible patients at the aforementioned hospitals until the requisite sample size is attained.

You may qualify if:

• Have been diagnosed with chronic atrophic gastritis;
• Be between the ages of 18 and 75, with no restrictions on gender;
• Read the informed consent form, sign it, and consent to participate in this study.

You may not qualify if:

• autoimmune gastritis (chronic atrophic gastritis type A);
• patients with gastroesophageal reflux disease (GERD) as determined by endoscopy or other examinations, or patients with high-grade intraepithelial neoplasia pathologically as determined by upper gastrointestinal endoscopy and gastric mucosal biopsy;
• patients with confirmed or unexcluded malignant tumors, particularly esophageal and gastric cancer;patients with other upper gastrointestinal pathologies, such as Barrett's esophagus or peptic ulcer;
• additional physical, mental, psychological, or pathological conditions that may impact sleep scores, such as the use of medications for insomnia, night shifts, jet lag, major events, severe neurosis, menopausal syndrome, uncontrolled hyperthyroidism, severe diabetic peripheral neuropathy, within a month after surgical trauma, etc.
• People who use medicines that can make you sleepy at the same time and stop using them for less than a month;
• People who can't finish the questionnaire because they're unconscious, can't talk regularly, or have other issues; people who don't have enough information.

Sponsors & Collaborators

• Yi Liang: lead
• Zhejiang Provincial Department of Science and Technology: collaborator

Study Sites (1)

the Ethics Board of Te Thnird Affiliated Hospital of Zhejjiang Chinese Medicinal University

Hangzhou, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum pepsinogen extracted and detected in venous blood samples

MeSH Terms

Conditions

Gastritis, Atrophic; Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Yi Liang, Doctor

CONTACT

+86 571 86633328; liangyiwww@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 4, 2025
• Study Start: March 30, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)